System and method for creating orthotics

ABSTRACT

Systems and methods for constructing custom orthotics are described. Several embodiments of the system use sensor pads to obtain both static and dynamic three dimensional information concerning the shape or topography of the bottom surface of a patient&#39;s foot. The information is analyzed to obtain information useful in constructing a custom orthotic from a selection of basic orthotic shells. Once constructed, the orthotic can modify a patient&#39;s gait. One embodiment of the present invention includes a user terminal including a sensor pad connected to a computer, a server configured to analyze three dimensional information acquired by the sensor pad, a manufacturing terminal configured to display the results of the server&#39;s analysis of the three dimensional information and a network that connects the user terminal to the server and the server to the manufacturing terminal.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This is a Continuation application of Ser. No. 11/076,580, filed Mar. 8,2005, now U.S. Pat. No. 7,346,418 which claims benefit of ProvisionalApplication No. 60/551,504 filed Mar. 8, 2004 the contents of which areexpressly incorporated herein by reference as if set forth in full.

BACKGROUND

The present invention relates generally to the field of informationcapture and more particularly to the capture of the three dimensionalshape of a human foot and the use of captured three dimensional shapeinformation to produce orthotics.

Orthotics are shoe inserts that are intended to correct an abnormal orirregular walking pattern. Orthotics perform functions that makestanding, walking and running more comfortable and efficient by alteringslightly the angles at which the foot strikes a surface. Orthotics takevarious forms and are constructed from various materials. Orthotics aregenerally concerned with improving foot function and minimizing stressforces that could ultimately cause foot deformity and pain.

A rigid orthotic is an orthotic designed to control foot function andcan be made of a firm material such as plastic or carbon fiber. Rigidorthotics are often designed to control motion in two major foot joints,which lie directly below the ankle joint. This type of orthotic iscommonly recommended by physicians in response to strains, aches andpains in the legs, thighs, and lower back. Rigid orthotics are generallyfabricated from a plaster of paris mold of an individual foot. Thefinished orthotic normally extends along the sole of the heel to theball or toes of the foot.

Soft orthotics can be used to absorb shock, increase balance and relievepressure from sore spots. Soft orthotics are typically constructed fromsoft, compressible materials and may be molded by the action of the footin walking or fashioned over a plaster impression of the foot. A usefulaspect of soft orthotics is that they may be easily adjusted to changingweight-bearing forces. However, material wear can require that they befrequently replaced. Use of soft orthotics has been shown to beeffective for treating arthritis suffers, people with foot deformitiesand patients suffering from diabetic foot. Soft orthotics are typicallyworn against the sole of the foot and extend from the heel past the ballof the foot to include the toes.

Semirigid orthotics provide for dynamic balance of the foot whilewalking or participating in sports. When used for participating insports, the nature of the sport can impact upon the orthotic design. Thepurpose of a semirigid orthotic is to help guide the foot through properfunctions, allowing the muscles and tendons to perform more efficiently.A basic semirigid orthotic can be constructed from layers of softmaterial that are reinforced with more rigid materials.

Orthotics have typically been constructed by using casting materials totake a mold of the subject's foot. The mold is then used to construct anorthotic that conforms to the base of the subject's foot. Various otherorthotics may be used for multidirectional sports or edge-control sportsby casting the foot within the shoe, such as a ski boot, ice skate boot,or inline skate boot.

SUMMARY OF THE INVENTION

Embodiments of the present invention can include a user terminal with asensor pad that is configured to acquire three dimensional informationconcerning the shape of a patient's foot. The three dimensionalinformation can be provided to a server that analyzes the informationand the analyzed information can be provided to a manufacturingterminal, where a technician can use the information to select and shapean orthotic shell. Alternatively, the information can enable theautomated manufacture of a custom orthotic. In one aspect of theinvention, custom orthotics can be constructed that modify the gait of apatient.

One embodiment of the present invention includes a user terminalincluding a sensor pad connected to a computer, a server configured toanalyze three dimensional information acquired by the sensor pad, amanufacturing terminal configured to display the results of the server'sanalysis of the three dimensional information and a network thatconnects the user terminal to the server and the server to themanufacturing terminal.

In another embodiment, the server is configured to determine a center ofbalance from the three dimensional information.

In a further embodiment, the server is configured to determine a gaitline from the three dimensional information.

In yet another embodiment, the server is configured to determine an archheight from the three dimensional information.

In a still further embodiment, the three dimensional informationincludes a single array of data describing the topography of a bottomsurface of a patient's foot.

In another embodiment again, the three dimensional information includesa plurality of arrays of data describing the topography of the portionsof a patient's foot contacting the footpad during dynamic motion. In astill further embodiment again, the server uses the plurality of arraysto identify the time spent in the contact, midstance and propulsivephases of a gait cycle.

An embodiment of the method of the invention includes acquiring threedimensional information concerning the shape of a patient's foot,analyzing the three dimensional information and displaying the threedimensional information and the analysis.

In a further embodiment of the method of the invention, the threedimensional information includes information acquired while the patientis stationary and information acquired while the patient is walking.

In another embodiment of the method of the invention, the analysisobtains information concerning the patient's center of balance.

In a still further embodiment of the method of the invention, theanalysis obtains information concerning the patient's gait line.

In yet another embodiment of the method of the invention, the analysisobtains information concerning the patient's arch.

In a still further embodiment again of the method of the invention, theanalysis obtains the proportion of time spent in the contact, midstanceand propulsive phases of a gate cycle.

In yet another embodiment again of the method of the invention, thedisplay is in the form of a printed information sheet.

In a still further additional embodiment, the display is in the form ofa graphical display on a computer screen.

In a yet another additional embodiment, the three dimensionalinformation can be displayed in a plurality of different ways.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a network in accordance with anembodiment of the present invention;

FIG. 2 is a schematic diagram of a user terminal in accordance with anembodiment of the present invention;

FIG. 3 is a schematic cross-sectional diagram of a footpad in accordancewith an embodiment of the present invention;

FIG. 4 is a schematic diagram of equipment located at a manufacturingfacility in accordance with an embodiment of the present invention;

FIG. 5 is a perspective view of an orthotic shell capable of being usedin conjunction with an embodiment of the method of the presentinvention;

FIG. 6 is a flow diagram illustrating a method of capturing threedimensional information concerning the shape of a foot in accordancewith an embodiment of the method of the present invention;

FIG. 7 is a flow diagram illustrating a method of dynamically capturingthree dimensional information concerning the shape of a foot in motionin accordance with an embodiment of the method of the present invention;

FIG. 8 is a schematic view of a graphical display of the topography ofthe bottom surface of a foot generated by a system in accordance with anembodiment of the present invention;

FIG. 9 is a flow diagram illustrating a process for generating a twodimensional height information display in accordance with an embodimentof the method of the present invention;

FIG. 10 is a schematic view of a two dimensional interpolated heightgraphic display generated in accordance with an embodiment of thepresent invention;

FIG. 11 is a flow diagram illustrating a process for generating a twodimensional interpolated height information display in accordance withan embodiment of the method of the present invention;

FIG. 12 is schematic view of a three dimensional contour map generatedin accordance with an embodiment of the present invention;

FIG. 13 is a flow diagram illustrating a process for generating a threedimensional contour map in accordance with an embodiment of the presentinvention;

FIG. 14 is a flow diagram illustrating a process for calculating thelocation of the center of mass of the force exerted on a footpad by thepatient's foot;

FIG. 15 is a flow diagram illustrating a process for displayinginformation concerning the shape of a foot during dynamic contact with asensing surface in accordance with an embodiment of the method of thepresent invention;

FIG. 16 is a flow diagram illustrating a process for generating a “gaitline” in accordance with an embodiment of the method of the presentinvention;

FIG. 17 is a flow diagram illustrating a process for calculating thepercentage of time spent in each of the contact, midstance andpropulsive phases of a gait cycle in accordance with an embodiment ofthe method of the present invention;

FIG. 18 is a flow diagram illustrating a process for storing patientinformation and transferring the information to a server in accordancewith an embodiment of the method of the present invention;

FIG. 19 is a flow diagram illustrating a process in accordance with thepresent invention for receiving and storing patient informationtransmitted by a user terminal over a network in accordance with anembodiment of the method of the present invention;

FIG. 20 is a flow diagram of a process for obtaining the arch height ofa patient's foot from three dimensional information provided by a userterminal in accordance with an embodiment of the method of the presentinvention; and

FIG. 21 is a flow diagram of a process for selecting an orthotic shellin accordance with an embodiment of the method of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Turning now to the drawings, a system for obtaining information usefulin the manufacture of orthotics is illustrated. One aspect of theinvention involves a network for collecting three dimensionalinformation concerning the shape of a patient's foot and transmittingthe information to a manufacturing facility. The patient information canbe collected using footpads, then processed and transmitted overtelephone lines or the internet. A manufacturing facility can receivethe transmitted information and the information used to generate anorthotic.

A system in accordance with an embodiment of the present invention forcollecting three dimensional information concerning the shape of apatient's foot and using the information to manufacture orthotics isillustrated in FIG. 1. The system 10 includes a number of user terminals12 that include footpads 14. The user terminals are connected to anetwork 16. A manufacturing terminal is also connected to the network16.

The user terminals collect information about a patient's foot using thefootpads. The information is processed at the user terminal and thensent to the server via the network. The server receives, processes andstores the information and then provides the information to themanufacturing terminal. A lab technician can use the manufacturingterminal to determine the appropriate construction of an orthotic.

A user terminal in accordance with an embodiment of the presentinvention is illustrated in FIG. 2. The user terminal 12 includes acomputer 30. The computer is connected to a footpad 14 and a modem 32.The modem is connected to a telephone line 34. In one embodiment, theuser terminal is a self activated kiosk in a retail outlet. In anotherembodiment, the user terminal is a station located in a doctor's office.Stations located in doctor's offices may contain some of thefunctionality attributed to other components of the system in accordancewith the present invention such as the server and/or the manufacturingterminal (see discussion below).

In several embodiments, the terminal captures three dimensionalinformation concerning the shape of the patient's foot using thefootpad. The captured information can then be displayed on the terminalor transferred to another computer over a telephone line using themodem. In other embodiments, the terminal is connected to a network viaa network interface card, cable modem or similar network interfacedevice.

A footpad in accordance with an embodiment of the present invention isillustrated in FIG. 3. The footpad is a sensor pad that includes a frame40 that possesses a base 42 and a series of sidewalls 44 that form atray. An array of electrode cells 46 are located on the bottom surfaceof the tray formed by the base and the sidewalls. The array of cells arecovered by a layer of conductive foam 48 and each electrode cell isconnected to an analog-to-digital converter 50. The analog-to-digitalconverter has an output 52. The conductive foam is covered by a layer ofnon-conductive material 54.

In one embodiment, the cells are square 24 karat gold plated electrodesthat have a side length of 1 cm and the conductive foam is anelectroconductive urethane foam. Any flexible and wear resistantnon-conductive material can be used to construct the layer ofnon-conductive material. In several embodiments, 1700 cells are used toform a 18.5 inch by 12 inch sensing area. In addition, the layer ofconductive foam has a thickness of 1 inch.

In other embodiments, other metals or piezoelectric materials can beused to construct the electrode cells. In other embodiments, othereletroconductive foams can be used to construct the layer of conductivefoam. In addition, a greater or lesser number of cells can be used tocreate footpads having larger or smaller sensing areas and/or higher orlower resolution.

In operation, patients places one or both of their feet on the layer ofnon-conductive material and the feet compress the foam. A localizedelectrical discharge occurs throughout the foam that is dependent uponthe amount of compression caused by a patient's foot. The localizeddischarge is detected by an adjacent electrode cell. Measurements of thecurrent in each of the electrodes can be indicative of the extent towhich the base of the patient's foot has compressed the foam in theregion above each of the electrode cells. The analog-to-digitalconverter can convert the measured currents into a digital signal thatis capable of being communicated to a computer.

In several embodiments, multiple footpads are used. In thisconfiguration, the user terminal can record measurements of a patientstriding from one footpad to the next.

Equipment that can be located at a manufacturing facility in oneembodiment of the present invention is illustrated in FIG. 4. Themanufacturing facility can include a server 18 that is connected to anetwork. In one embodiment, the network is the telephone network and theserver is connected to the network via a modem 60 connected to atelephone line 62. In other embodiments, the network is an Ethernet, theinternet or another type of network over which digital information canbe transferred and the server is connected to the network via anappropriate network interface. A manufacturing terminal 20 is alsoconnected to the network via a modem 64 connected to a telephone line66. The manufacturing terminal includes a computer 68 and a printer 22.Although the server is shown as being present at a manufacturingfacility, in other embodiments the server can be located remote from themanufacturing facility.

The server receives three dimensional information concerning the shapeof a patient's foot and performs analysis of this information togenerate parameters that are useful in the manufacturing process. Theinformation and the parameters are then transferred via the network tothe manufacturing terminal, where a technician can view the informationand be guided by the generated parameters in the selection of anorthotic shell that can then be modified to create an orthoticcustomized to the shape of the patient's foot. In one embodiment of thesystem, the technician has a number of different types of orthoticshells that can be used to create custom orthotics and the mostappropriate shell is indicated by the parameters determined by theserver from the three dimensional information of the patient's foot.

An exemplary orthotic shell in accordance with an embodiment of thepresent invention is illustrated in FIG. 5. The shell can be modifiedusing a heat gun or similar device to increase or decrease arch heightor modify any other aspect of the orthotic shell's shape.

The hardware described above is operated in conjunction with software.The following provides a description of various software routines thatcan be used in accordance with embodiments of the present invention tooperate the hardware described above.

The user terminal 12 captures three dimensional information concerningthe shape of a patient's foot. In one embodiment, software enables thehardware to capture this information statically and dynamically. A flowchart illustrating a process that can be implemented using the hardwaredescribed above and software for capturing three dimensional informationof the shape of a patient's foot in accordance with an embodiment of thepresent invention is illustrated in FIG. 6. The process 70 includesdetecting (72) that a patient is positioned on the footpad. Theanalog-to-digital converter is then normalized (74) using the bisectionmethod to search the range of the analog-to-digital converter for thehighest sensitivity level at which the analog-to-digital converter isnot saturated. Once the analog-to-digital converter has been normalized,a sample of all the electrode cells is taken (76). The samples arestored (78) as an array in memory. The process is then repeated withincreasing (82) levels for the analog-to-digital converter until themaximum level of the analog-to-digital converter is reached (80). In oneembodiment, the range of sensitivities above the normalized level of theanalog-to-digital converter is divided by six and six measurements aretaken by adding the result of the division to the sensitivity of theprevious measurement. Once the maximum level has been reached, themeasurement is completed (84).

The normalization of the analog-to-digital converter enables the systemto choose the level of sensitivity that provides the greatest amount ofinformation for each patient. A heavier person will saturate many of theelectrode cells at a high level of analog-to-digital convertersensitivity and a lighter person will generate currents that appearuniform at a low level of analog-to-digital converter sensitivity. Byusing the bisection method to locate the maximum sensitivity of theanalog-to-digital converter, a data set can be obtained that possesses asignificant range of values without saturation.

A flow chart illustrating a process that enables the capture of threedimensional information concerning the shape of a patient's foot, whenthe foot is in motion, is shown in FIG. 7. The process 100 includesnormalizing the analog-to-digital converter in the manner describedabove and then scanning (102) the electrode cells. If no pressure isdetected, then the process pauses (103) and a new scan is taken untilpressure is detected. Once pressure is detected (104), the scanned datais stored (106), a timer is started and the process pauses (107) beforescanning (108) the electrode cells again. The scan is stored if pressureis detected (110). The process continues to scan and store data untilpressure is no longer detected (110) on the footpad or the timer timesout.

In addition to capturing information using the footpad, the userterminal in accordance with an embodiment of the present invention candisplay the captured information. The information can be displayed inone of a number of manners. In one embodiment, three dimensionalinformation concerning the shape of a patient's foot can be displayed asa two dimensional height information display, a two dimensionalinterpolated height information display or a three dimensional contourmap.

An example of a two dimensional height information display generated inaccordance with an embodiment of the present invention is illustrated inFIG. 8. The display includes a grid 120 of cells. Each cell correspondsto information collected by an electrode cell in the footpad. Themajority of cells do not contain information concerning the shape of apatient's foot and a 16×33 cell grid is chosen that contains all of thepressure information generated by the patient's foot. The grid squaresthat contain pressure information concerning the patient's foot areindicated by a number 122 and a dot 124. The number indicates the heightof the patient's foot at that point measured relative to the lowestpoint of the patient's foot. The size and color of the dot are assignedbased on the height information. Numbers that are small are assignedlarge dots with a red color. As the number increases smaller dots withcolors trending from red to yellow to green to blue are assigned. Cellswhere no pressure was detected from the patient's foot 126 are leftempty.

A process for generating a two dimensional height information display inaccordance with an embodiment of the present invention is illustrated inFIG. 9. The process 130 includes retrieving (132) the appropriate arrayof data for display. A grid is generated (134) that is capable of beingdisplayed on a computer screen. The portion of the stored array of datathat contains information concerning the shape of the patient's foot isthen determined (136) from the retrieved array of data. This data isthen used to assign (138) numerical values and color spots to the gridlocations corresponding to the electrode cells from which the data wasrecorded. The information is then displayed (140) on a computer screen.The information can also be converted to a format that is capable ofbeing printed by a printer. In one embodiment, the software TeeChartdistributed by Steema Software of Catalonia, Spain can be used togenerate the display.

An example of a two dimensional interpolated height information displaygenerated in accordance with an embodiment of the present invention isillustrated in FIG. 10. The image 150 includes a grid 152 that depictsthe scale of the information presented. Superimposed on the grid arepixels of color that indicate the height of the surface of the undersideof a patient's foot above an arbitrary reference surface. Theinformation displayed has a higher resolution than the informationcollected using the footpad. The increased resolution is obtained byinterpolating the raw data. A black dot 156 is superimposed on the imageto indicate the center of balance of the foot.

A process for generating a two dimensional interpolated heightinformation display in accordance with an embodiment of the presentinvention is illustrated in FIG. 11. The process 170 includes retrieving(172) the relevant array of data. The data is then smoothed (174) togenerate an interpolated data set. A commercial software routine such asTeeChart can be used to generate the interpolated data set. Once theinterpolated data set is generated, each point of the interpolated datacan be assigned (176) a color based on the relative height of pointabove the base of the footpad. A grid is then generated (178) and thecells of the grid that include interpolated data are identified (180).The data can then be displayed (182) by superimposing the data over therelevant squares of the grid.

An example of a three dimensional contour map generated in accordancewith an embodiment of the present invention is illustrated in FIG. 12.The image 190 includes a three dimensional contour map 192 of each foot.The contour map uses a combination of contour lines 194 and color 196 tocreate the illusion of a three dimensional surface on the twodimensional computer screen. The contour lines and the colors are chosento represent a three dimensional shape corresponding to the surface ofthe patient's foot.

A process for generating a three dimensional contour map in accordancewith an embodiment of the present invention is illustrated in FIG. 13.The process 200 in accordance with the present invention includesretrieving (202) the scan information and generating (204) a contour mapusing adjacent data points. In one embodiment, a commercial contourmapping engine such as TeeChart can be used to generate the contour map.The retrieved information can also be used to generate (206) aninterpolated data set in the manner described above in relation to FIG.11. Once colors are assigned to the interpolated data set to representthe relative height of each of the data points, the interpolated dataset is superimposed (210) onto the contour map. The contour map and thesuperimposed interpolated data set are then displayed (212).

Referring back to FIG. 12, the center of balance 156 is shown as blackdot superimposed on the image of the patient's foot. A process that canbe used in accordance with one embodiment of the present invention tocalculate the location of the center of mass of the force exerted on thefootpad by the patient's foot is illustrated in FIG. 14. The process 220involves taking (222) a weighted average of the grid co-ordinates of thedata points. Each grid location is weighted according to the amount ofpressure exerted on that grid cell by the patient's foot. The amount ofpressure is determined using the height data collected using thefootpad. The weighted average is the center of balance. The gridlocation of the center of balance is determined (224) and thensuperimposed (226) over the height information display. The center ofbalance can be superimposed over whichever display mode is being used todisplay the height information collected by the footpad.

As discussed above, a user terminal in accordance with an embodiment ofthe present invention is capable of capturing information dynamically.Dynamic information capture can be used to obtain information concerningthe manner in which the undersurface of a patient's foot changes shapeas the patient walks or runs.

An embodiment of a process for obtaining information concerning theshape of a patient's foot during motion was described above in relationto FIG. 7. A process in accordance with an embodiment of the presentinvention for displaying information concerning the shape of a patient'sfoot during motion is illustrated in FIG. 15. The process 240 includesretrieving (242) a first frame of stored data. The frame of data is thenprocessed to generate an image in a desired format. Typically thedesired format will be either a two dimensional interpolated heightinformation display or a three dimensional contour map. The twodimensional interpolated height information display or the threedimensional contour map can be generated in accordance with thedescription provided above. The image frame is then stored (246) and adetermination (248) is made as to whether any additional frames of datawere captured. If additional frames of data exist, then each of theseframes is retrieved and an image in the desired format is generated andstored. The process repeats until no additional frames of data remain.Once images have been generated from each of the frames of data, thenthe sequence of image frames can be displayed (250) on a computerscreen. If sufficient processing power exists, the display of the imageframes can occur simultaneously with the generation of the images forlater frames of data.

In addition to displaying information concerning the shape of apatient's foot, user terminals in accordance with the present inventionare capable of analyzing a patient's gait. During the display of thedynamic information, the user terminal can show the location of thecenter of balance in each frame, display the elapsed time, thepercentage and duration of time spent on three important phases of thegait cycle (i.e. the contact, midstance and propulsive phases) and/orthe “gait line”, which is a composite of all of the center of balancefor each frame of the dynamic information.

In one embodiment, the center of balance in each frame is calculatedusing the process described above in relation to FIG. 14. The “gaitline” is simply a line corresponding to the change in the location ofthe center of balance as the patient's foot contacts the footpad andthen lifts from the footpad. An embodiment of a process in accordancewith the present invention for generating a “gait line” from frame datacaptured using a footpad is illustrated in FIG. 16. The process 260includes retrieving (262) a first frame of data. The retrieved data isused to generate (264) an image frame in a desired format in a similarmanner to that discussed above in relation to FIG. 15. The center ofbalance for the frame is then calculated using the retrieved data in amanner similar to that described above in relation to FIG. 14. Thelocation of the center of balance is then used to form the “gait line”.The “gait line” starts at the location of the center of balance for theinitial frame and then is formed (268) by extrapolating from the centerof mass from the previous frame to the center of mass of the currentframe. The “gait line” is then superimposed (270) on the image frame andthe result is stored (272). If there are additional frames of data(274), then the process is repeated. Otherwise the sequence of imageframes can be sequentially displayed (276) on a computer screen.

In other embodiments, a similar process can be used simply to generatethe “gait line” without generating the image frame information. The“gait line” can then be superimposed on a static image of the patient'sfoot.

An embodiment of a process in accordance with the present invention forcalculating the percentage of time spent in each of the contact,midstance and propulsive phases of the gait cycle is illustrated in FIG.17. The process 290 involves retrieving (292) frames of stored data andtagging (294) each frame with a “phase tag” that is initialized toindicate the contact phase of the patient's gait. Once each “phase tag”has been initialized, the first frame is examined (296) to determine(298) the row number of the row of cells that contain data and areclosest to the front (i.e. the end of the toes) of the patient's foot.Then the next frame in the sequence of frames is examined (296) todetermine the row number of the row of cells that contain data and areclosest to the front of the foot. The two row numbers are compared (300)and if they differ by four or more, then the second frame in thesequence of frames is tagged (302) as being part of the midstance phasein the gait cycle. If the row numbers of the frames do not differ byfour or more, then the next frame in the sequence of frames is examined(296) and the frame is compared (300) with the previous frame untilthere are no more frames or the difference in the row numbers is four ormore. Once a midstance frame has been identified, the process ofexamining frames (304, 306, 308) and comparing them to previous framescontinues. However, the comparison (308) is made with a view todetermining whether the row number of the row that is closest to theback of the foot (i.e. the heel) is two or more greater than theequivalent row number for the previous frame. Once a frame is locatedwhere the row number of the row of cells that contain data and areclosest to the back of the foot is two or more greater than the previousframe, then that frame and all subsequent frames are tagged (310) asbeing part of the propulsive phase of the gait cycle. The proportion ofthe gait cycle spent in each phase can then be calculated (312) bydetermining the number of frames tagged as being part of each phase as aproportion of the number of frames in the gait cycle.

As described above, the user terminal can store the raw informationobtained from the footpad in a database and then transmit theinformation to a server. An embodiment of a process in accordance withthe present invention for storing the information and then transferringthe information to a server is illustrated in FIG. 18. The process 320includes retrieving (322) the stored information that is to be sent tothe server. The retrieved information is compressed (324) a connectionis established with a server and the compressed information istransferred (326) to the server using a file transfer protocol.

In other embodiments, other techniques involving the transfer of digitalinformation can be used to transfer the three dimensional informationconcerning the shape of a patient's foot to a server. In otherembodiments, additional information such as the image information thatcan be displayed using a computer is also transferred.

As discussed above, a server receives information transmitted by userterminals, stores the information in a database, performs operations toobtain custom fitting parameters and transfers the information and thecustom fitting parameters to a manufacturing terminal.

An embodiment of a process in accordance with the present invention forreceiving and storing information transmitted by a user terminal over anetwork is illustrated in FIG. 19. The process 340 includes receiving(342) a request to initiate a file transfer. Receiving (344) a filetransferred using the file transfer protocol. Decompressing (346) thefile to yield three dimensional information concerning a patient's footand then storing (348) the information in a database.

Similar methods to those illustrated in FIGS. 18 and 19 can be used totransfer data between a server and a manufacturing terminal.

A server in accordance with an embodiment of the present invention cananalyze the three dimensional information concerning the shape of apatient's foot that is provided by a user terminal. In one embodiment,the server analyzes the three dimensional information to obtain customfitting parameters such as the arch height of the patient's foot, centerof balance for each foot and center of balance for the patient. Inseveral embodiments, batch processing of three dimensional informationis performed. In other embodiments, three dimensional information isanalyzed as it is received.

An embodiment of a process in accordance with the present invention forobtaining the arch height of a patient's foot from the three dimensionalinformation provided by a user terminal is illustrated in FIG. 20. Theprocess 360 involves retrieving (362) the three dimensional informationconcerning the shape of the patient's foot. The arch of the patient'sfoot is then located (364). The arch can be located by ignoring thefirst column of data on the arch side of the foot and then locating atrapezoid of 15 cells (a column of 9 cells adjacent a column of 7 cellsadjacent a column of 5 cells) that has the highest average height. Thearch height can then be determined by interpolating (366) the cells. Theinterpolation can be determined by curve fitting the informationpossessed in relation to each of the fifteen cells. The interpolateddata is then smoothed (368). The arch height is then determined (376) asthe highest point of the smoothed interpolated arch data. Depending onwhether a patient has a hypermobile, rectus or cavus foot, the value ofthe arch height is multiplied (374) by an adjustment factor. Theadjustment factor serves to correct problems associated with the mannerin which the patient's foot moves during his or her gait. In oneembodiment, the calculated arch height value of a hypermobile foot isadjusted by a factor of 2.5. The arch height of a rectus foot isadjusted by a factor of 1.5 and the arch height of a cavus foot isadjusted by 0.5. In other embodiments, other adjustment factors forcorrecting gait abnormalities can be used.

In several embodiments, position arrows are displayed on the images of apatient's foot displayed on a manufacturing or user terminal. Theseposition arrows show the center of balance for each of a patient's feetand the patient's overall center of balance. The location of theposition arrows can be determined by taking a weighted average in themanner described above. The position arrows can be supplemented withinformation showing a “normal” range of values for the location of thevarious centers of balance.

As discussed above, the server provides the three dimensionalinformation concerning the shape of a patient's foot and the customfitting parameters to a manufacturing terminal via the network. Thisinformation is used for the manufacturing of an orthotic customized tofit the patient's foot. A process that can be used by a technician inaccordance with the practice of the present invention to select anorthotic shell from which to make the custom fitted orthotic isillustrated in FIG. 21. The process 380 includes obtaining (382) aninformation sheet that includes the estimated arch height of each of thepatient's feet (determined as described above). The technician thendetermines the patient's foot type (384) by examining the twodimensional height information displays and video of the patient's gaitand modifies (386) the arch height in the manner described above inaccordance with the foot type. In other embodiments, the patient's foottype can be specified by the doctor and modification performedautomatically and provided to the technician. The foot size and modifiedarch height are then used to select (388) an orthotic shell, similar tothe shell illustrated in FIG. 5, having a shape closest to the requiredshape. The arch height of the orthotic shell can then be adjusted (390)using a heat gun to achieve the desired shape. In other embodiments,software can be used to control one or more machine tools to automatethe process of manufacturing an orthotic.

Although the foregoing embodiments are disclosed as typical, it would beunderstood that additional variations, substitutions and modificationscan be made to the system, as disclosed, without departing from thescope of the invention. For example, other distributions of thefunctions of the system across the various elements of the system couldbe used to obtain information, process information and manufactureorthotics using the processed information. Accordingly, the scope of theinvention should be determined not by the embodiments illustrated, butby the appended claims and their equivalents.

1. A system for manufacturing custom orthotics comprising: a sensor padfor acquiring three dimensional information concerning a topography of asole of a patient's foot, the sensor pad for acquiring utilizingpressure applied by the patient's foot and comprises a plurality ofelectrode cells comprising piezoelectric materials for acquiring static,dynamic, or both static and dynamic topography information; means forcommunicating the topography information: a server for receiving thetopography information and analyzing the topography information; adisplay for displaying the topography information and the analysis ofthe topography information; wherein the three dimensional informationincludes an array of data describing the topography of portions of thepatient's foot; and the displayed topography information comprisesinformation from at least seven cells each having a highest averageheight value.
 2. The method of claim 1, further comprising selecting anorthotic shell from a plurality of different types of orthotic shellsand modifying the selected shell based on the analysis to more clearlymatch the analyzed topography information to manufacture a customorthotic.
 3. The method of claim 1, wherein the analysis obtainsinformation concerning the patient's center of balance, which comprises,at least in part, a weighted average of a grid coordinate of data pointsweighted according pressure exerted on respective electrode cells by thepatient's foot.
 4. A method of manufacturing a custom orthotic,comprising: acquiring measurements in three dimensions concerning ashape of a patient's foot, the acquiring measurements utilizing pressureof the patient's foot on a sensor pad; analyzing the measurements;displaying the measurements and the analysis, the measurements includean array of data describing the topography of portions of the patient'sfoot gathered from a plurality of electrode cells comprisingpiezoelectric materials located in the sensor pad; and the analysisobtains information concerning the patient's arch, which compriseslocating a trapezoid of cells that has highest average heights ofreviewed cells and selecting points among the reviewed cells.
 5. Themethod of claim 4, wherein three dimensional info a on includesinformation acquired while the patient is stationary and informationacquired while the patient is in motion.
 6. The method of claim 4,wherein the analysis obtains information concerning the patient's centerof balance, which comprises, at least in part, a weighted average of agrid coordinate of data points weighted according pressure exerted onrespective electrode cells by the patient's foot.
 7. The method of claim4, wherein the analysis obtains information concerning the patient'sgait line.
 8. The method of claim 4, wherein the analysis obtains theproportion of time spent in the contact, midstance and propulsive phasesof a gait cycle.
 9. The method of claim 4, wherein the display is in theform of a printed information sheet.
 10. The method of claim 4, whereinthe acquiring is performed while the patient's foot is staticallycontacting the sensor pad.
 11. The method of claim 4, further comprisingselecting an orthotic shell from a plurality of different types oforthotic shells based on the analysis.
 12. The method of claim 4,further comprising selecting an orthotic shell from a plurality ofdifferent types of orthotic shells and modifying the selected shellbased on the analysis to form a custom orthotic.
 13. The method of claim12, wherein a heat gun is utilized in modifying the selected shell. 14.The method of claim 12, where modifying the selected shell includeschanging arch height.
 15. A system for manufacturing custom orthoticscomprising: a reader for acquiring three dimensional informationconcerning a topography of a sole of a patient's foot when the foot isin contact with the reader, the reader utilizes pressure applied by thepatient's foot to acquire the topography information; a transmittingdevice for communicating the topography information; a server forreceiving the topography information and for analyzing the topographyinformation; a display for displaying the topography information and theanalysis of the topography information; and wherein the threedimensional information includes an array of data describing thetopography of portions of the patient's foot and the display oftopography information comprises a display of two dimensionalinterpolated height information with a center of balance display of thepatient's foot superimposed on the two dimensional interpolated heightinformation.
 16. The system of claim 15, further comprising a pluralityof different types of orthotic shells having different shapes, andwherein at least one of the orthotic shells has a shape that closelymatches the analysis to require minimal modification to match theanalysis.
 17. The system of claim 15, wherein the analysis obtainsinformation concerning the patient's center of balance, which comprises,at least in part, a weighted average of a grid coordinate of data pointsweighted according pressure exerted on respective electrode cells by thepatient's foot.
 18. The system of claim 15, wherein the reader comprisesa plurality of electrode cells comprising piezoelectric materials. 19.The system of claim 18, further comprising conductive foam in contactwith the electrode cells.